510(k) Report

Devices descending from K180921

3 later devices reach Sapphire II PRO Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252295RyureiTerumo Corporation20260—
+1K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+1K200269Sapphire II PROOrbusneich Medical Trading, Inc.20200—